Analysis of Prevalence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients who underwent POEM.
- Who it may be relevant to
- Registry conditions: Achalasia, GERD. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Analysis of Incidence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy
Overview
Achalasia is an uncommon disorder that results from the degeneration of ganglion cells of the myenteric plexus in the lower esophageal wall. Peroral endoscopic myotomy (POEM) is a minimally invasive procedure capable of overcoming limitations of achalasia treatments. This study aimed to: 1) identify the prevalence of reflux esophagitis and asymptomatic GERD in patients who underwent POEM, and 2) evaluate patient and intraprocedural variables associated with post-POEM GERD.
Interventions
- Other Patients who underwent POEM
chalasia patients were recruited from a single center. The pre- and postoperative assessments included Eckardt scores, GerdQ questionnaire, high-resolution esophageal manometry, esophagogastroscopy and pH monitoring.
Primary outcome measures
- The prevalence of gastroesophageal reflux after peroral endoscopic myotomy (POEM) [Time frame: 36 Months]
Eligibility criteria
Inclusion criteria
- Males and females who are 18 years of age and older and are willing to sign an Informed Consent Form (ICF)
- Achalasia patients who underwent POEM
Exclusion criteria
- Lack of written consent for participation in the study
- Conditions which are contraindication to Esophagogastroscopy and High-resolution Esophageal Manometry
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Poland · 1 center
- Maria Sklodowska-Curie Institute - Oncology Center — Warsaw
Identifiers
NCT: NCT05080634 · 22042020